Adverse Events and Recalls

US Pharmacopeia documents best supply-chain practices and seeks broad input on proposal.

GlaxoSmithKline is recalling 394,230 bottles containing its antihypertensive drug DynaCirc CR (isradipine) controlled-release tablets. The lots are being recalled due to concerns regarding the level of cGMP compliance and procedural controls related to line clearance during the packing process at the Lincoln, Nebraska, facility of Novartis Consumer Health, where the product is made.

On Feb. 17, 2012, McNeil Consumer Healthcare, a division of McNeil-PPC, a subsidiary of Johnson & Johnson, voluntarily recalled approximately 574,000 bottles of its OTC pain reliever and fever reducer Infants' Tylenol Oral Suspension, 1 oz. Grape. The voluntary recall was initiated after consumers complained of having difficulty using the SimpleMeasure dosing system.

New Web Search Feature on FDA.gov, Search for Product Recalls More Quickly

Johnson & Johnson's run of quality issues, recalls and other bad news continues with yet another product recall.

Pfizer Recalls One Lipitor Lot; Sanofi Aventis Names Head of R&D; and More.

During the 20 months before the crisis of contaminated heparin in early 2008, the US Food and Drug Administration did not inspect any Chinese heparin firms, according to a US Government Accountability Office, (GAO) report.

Pfizer (New York) announced on Oct. 29, 2010 that it intends to recall two additional lots--approximately 38,000 bottles--of Lipitor (atorvastatin calcium) 40 mg tablets distributed in the United States.

Amgen (Thousand Oaks, CA) issued a voluntary recall last week of certain lots of Epogen(R) and Procrit(R) (Epoetin alfa) vials.

About one month after the announcement of McNeil Consumer Healthcare's recall of children's liquid pain and allergy medications , the US Food and Drug Administration testified before the US House Committee on Oversight and Government Reform about the issue.

McNeil Consumer Healthcare is voluntarily recalling all lots that have not yet expired of certain over-the-counter children's and infants' liquid products.

McNeil Consumer Healthcare is voluntarily recalling certain lots of over-the-counter products in the Americas, the United Arab Emirates, and Fiji.

The United States Pharmacopeial Convention is recalling USP 33?NF 28.

The FDA has said it would like to amend postmarket safety reporting regulations ?to require that manufacturers and other facilities subject to current reporting requirements submit their reports in an electronic format".

The US Food and Drug Administration announced in an Aug. 20, 2009 release that it would like to amend postmarket safety reporting regulations "to require that manufacturers and other facilities subject to current reporting requirements submit their reports in an electronic format."

The US Food and Drug Administration released a new guidance for industry, Medication Guides-Adding a Toll-Free Number for Reporting Adverse Events, on June 8, 2009.

The International Serious Adverse Event Consortium (SAEC), a nonprofit partnership, has helped the US Food and Drug Administration gain significant understanding of the genetic basis for drug-induced liver injury, according a new FDA press release.

The US Food and Drug Administration posted the Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan on its website.

Actavis Totowa LLC, the US subsidiary of the generic drug manufacturer Actavis Group, is announcing a voluntary recall to the retail level of all drug products manufactured at its Little Falls, New Jersey, facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.

FDA is modernizing adverse-event reporting as part of a revolution in drug-safety assessment.

In an assessment report about medicinal products containing heparin, the European Medicines Agency (EMEA)'s Committee for Medicinal Products for Human Use (CHMP) said it could not draw firm conclusions about the level of risk associated with unfractionated heparins (UFH) contaminated with oversulfated chondroitin sulfate (OSCS). Nevertheless, CHMP recommended that contaminated lots be withdrawn completely.

Also, FDA removes OAI status for Watson's Florida facility, executive management changes as GSK, more...

Problems associated with contamination of heparin products continue after worldwide recalls in March in the United States, Italy, France, and Denmark.

Baxter Healthcare Corporation is providing an update to its January 2008 heparin sodium injection 1000 units/mL 10 and 30mL multi-dose vial voluntary recall of nine lots, which the company initiated as a precautionary measure due to an increase in reports of adverse reactions that may be associated with the drug.

Wyeth Consumer Healthcare launched a voluntary recall and replacement program for US retail outlets that sell several ?Robitussin? and ?Children?s Dimetapp Cold and Chest Congestion? products.

Boehringer Ingelheim decided to voluntarily withdraw its “Silomat” drug, which contains clobutinol hydrochloride, in all countries where it is available.

Basel, Switzerland (June 6)-Roche, in an agreement with the European Medicines Agency and the Swiss Agency for Therapeutic Products, recalled all batches of "Viracept" (nelfinavir) powder and tablets in Europe and some other regions of the world.

Over-the-counter drug maker Perrigo Company issued a voluntary recall of certain lots of store-brand acetaminophen 500-mg caplets that could contain trace amounts of metal particulate. Approximately 11 million bottles of acetaminophen are affected by the recall.

The US Food and Drug Administration's Center for Drug Evaluation and Research executed 45 Class I, 193 Class II, and 128 Class III recalls of human drugs between Oct. 1, 2005 and Sept. 30, 2006.

Schering AG (Berlin, Germany) voluntarily issued a worldwide recall of all lots of its X-ray contrast agent "Ultravist Injection" 370 mgI/mL (iopromide injection) because particulate matter and crystallization may be present in the product.